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临床试验/CTIS2023-505874-14-00
CTIS2023-505874-14-00招募中1 期

A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD]) - TT-TSND-201

Transcend Therapeutics Inc.0 个研究点目标入组 79 人开始时间: 2023年6月8日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
79

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months. (The PTSD diagnosis will be confirmed at Baseline by the central rater)., CAPS-5 score of ‚ =35 at Screening and =28 at Baseline., Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment)., Proficient in reading and writing in local language sufficient to complete questionnaires., Free from any other clinically significant illness or disease

排除标准

  • Primary diagnosis of any other DSM-5 disorder, Body mass index (BMI) <18 kg/m2 or ‚=40 kg/m2, Smokes an average of >10 cigarettes and/or e-cigarettes per day, Uncontrolled hypertension at Screening, Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening., Use of an SSRI or other antidepressant within 8 weeks of screening, Current or previous history of clinically significant cardiovascular/cerebrovascular conditions

研究者

发起方
Transcend Therapeutics Inc.

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